A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
- Conditions
- Diabetes MellitusDiabetic RetinopathyDiabetic Macular Edema
- Interventions
- Drug: THR-149 dose level 1Drug: THR-149 dose level 2Drug: THR-149 dose level 3Drug: THR-149 0.13mgDrug: THR-149 0.13mg + aflibercept 2mg
- Registration Number
- NCT04527107
- Lead Sponsor
- Oxurion
- Brief Summary
Part A of the study is conducted to select the THR-149 dose level.
Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
- Written informed consent obtained from the subject prior to screening procedures
- Male or female aged 18 years or older at the time of signing the informed consent
- Type 1 or type 2 diabetes
- BCVA ETDRS letter score ≤ 73 and ≥ 39 in the study eye (for subjects in Part A); BCVA ETDRS letter score ≤ 73 and ≥ 24 in the study eye (for subjects in Part B)
- Central involved DME (CI-DME) with CST of ≥ 320µm in men or ≥ 305µm in women, on spectral domain optical coherence tomography (SD-OCT), in the study eye
- Received ≥ 5 anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of CI-DME
- BCVA ETDRS letter score ≥ 34 in the fellow eye
Key
- Macular edema due to causes other than DME in the study eye
- Concurrent disease in the study eye, other than central-involved DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
- Any condition that could confound the ability to detect the efficacy of the investigational medicinal product
- Previous confounding medications / interventions, or their planned administration
- Presence of neovascularisation at the disc in the study eye
- Presence of iris neovascularisation in the study eye
- Uncontrolled glaucoma in the study eye
- Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
- Untreated Diabetes Mellitus
- Glycated haemoglobin A (HbA1c) > 12%
- Uncontrolled hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aflibercept + sham Aflibercept 2mg - THR-149 dose level 1 THR-149 dose level 1 - THR-149 dose level 2 THR-149 dose level 2 - THR-149 dose level 3 THR-149 dose level 3 - THR-149 + sham THR-149 0.13mg - THR-149 + aflibercept flip-over THR-149 0.13mg + aflibercept 2mg - Aflibercept + THR-149 flip-over aflibercept 2mg + THR-149 0.13mg -
- Primary Outcome Measures
Name Time Method Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study At Month 3
- Secondary Outcome Measures
Name Time Method Mean change in BCVA ETDRS letter score from Baseline, by study visit Up to Month 6 Mean change in central subfield thickness (CST) from Baseline, by study visit Up to Month 6 Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs) Up to Month 6
Trial Locations
- Locations (78)
Northern California Retina Vitreous Associates Medical Group, Inc.
🇺🇸Mountain View, California, United States
Blue Ocean Clinical Research
🇺🇸Clearwater, Florida, United States
Retina Associates of Cleveland, Inc
🇺🇸Cleveland, Ohio, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Austin Research Center for Retina
🇺🇸Austin, Texas, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Retina Research Center, PLLC
🇺🇸Austin, Texas, United States
Retina Associates
🇺🇸Tucson, Arizona, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
California Retina Consultants
🇺🇸Oxnard, California, United States
Marietta Eye Clinic
🇺🇸Marietta, Georgia, United States
Salehi Retina Institute Inc.
🇺🇸Huntington Beach, California, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Všeobecná fakultní nemocnice v Praze
🇨🇿Praha 2, Czechia
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Retina Consultants San Diego
🇺🇸Poway, California, United States
University Retina and Macula Associates, PC
🇺🇸Oak Forest, Illinois, United States
IRCCS Fondazione G.B. Bietti
🇮🇹Roma, Italy
Hospital de la Esperanza
🇪🇸Barcelona, Spain
Hospital Dos de Maig
🇪🇸Barcelona, Spain
Fort Lauderdale Eye Institute
🇺🇸Plantation, Florida, United States
CHU de Dijon
🇫🇷Dijon, France
MedEye Associates
🇺🇸South Miami, Florida, United States
Retina Consultants of Southern Colorado, P.C.
🇺🇸Colorado Springs, Colorado, United States
Hospital General de Catalunya
🇪🇸Barcelona, Spain
IRCCS Ospedale San Raffaele
🇮🇹Milan, Italy
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States
Fondation Rothschild
🇫🇷Paris, France
Hôpital de la Croix Rousse
🇫🇷Lyon, France
METAVISIÓN ARRUZAFA, S.L.Clínica de Oftalmología de Córdoba S.L. (Hospital La Arruzafa)
🇪🇸Córdoba, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Wagner Macula & Retina Center
🇺🇸Norfolk, Virginia, United States
Centre Paradis Monticelli
🇫🇷Marseille, France
Frimley Health NHS Foundation Trust
🇬🇧Frimley, United Kingdom
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Fakultná nemocnica s poliklinikou Žilina
🇸🇰Žilina, Slovakia
University Hospitals Bristol NHS Foundation Trust
🇬🇧Bristol, United Kingdom
Hôpital Lariboisière
🇫🇷Paris Cedex 10, France
Internationale Innovative Ophthalmochirurgie
🇩🇪Düsseldorf, Germany
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
Retinal Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Tenneesse Retina
🇺🇸Nashville, Tennessee, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
Retina Consultants of Houston, PA
🇺🇸Houston, Texas, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Retina Associates of South Texas, P.A.
🇺🇸San Antonio, Texas, United States
Retina Consultants of Texas
🇺🇸San Antonio, Texas, United States
Retina Associates of Utah
🇺🇸Salt Lake City, Utah, United States
Retina-Vitreous Surgeons of Central New York, PC
🇺🇸Liverpool, New York, United States
Hospital Universitario Rio Hortega
🇪🇸Valladolid, Spain
Sterling Vision, P.C. dba Oregon Retina
🇺🇸Eugene, Oregon, United States
Valley Retina Institute, PA
🇺🇸McAllen, Texas, United States
WVU Eye Institute
🇺🇸Morgantown, West Virginia, United States
Universitätsklinikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Centre Hospitalier Intercommunal de Créteil
🇫🇷Créteil, France
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Azienda Sanitaria Universitaria Friuli Centrale
🇮🇹Udine, Italy
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Madrid, Spain
Instituto Oftalmológico Gómez-Ulla
🇪🇸Santiago De Compostela, Spain
Fundación de Oftalmología Médica de la Comunitat Valenciana
🇪🇸Valencia, Spain
Instituto Clínico Quirúrgico de Oftalmología
🇪🇸Bilbao, Spain
Kent and Canterbury Hospital
🇬🇧Canterbury, United Kingdom
London North West University Healthcare NHS Trust
🇬🇧London, United Kingdom
Mid and South Essex NHS Foundation Trust
🇬🇧Westcliff-on-Sea, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Universitätsklinikum Regensburg
🇩🇪Regensburg, Germany
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Moorfields Eye Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
South Tyneside and Sunderland NHS Foundation Trust
🇬🇧Sunderland, United Kingdom
Retinal Consultants Medical Group
🇺🇸Sacramento, California, United States